Time to absolute and relative declines in forced vital capacity (FVC) ≥5% predicted or ≥10% predicted using data up to the final database lock in the INBUILD trial
| Overall population | Subjects with UIP-like fibrotic pattern on HRCT | |||
| Nintedanib (n=332) | Placebo (n=331) | Nintedanib (n=206) | Placebo (n=206) | |
| Absolute decline in FVC ≥5% predicted | 217 (65.4) | 263 (79.5) | 137 (66.5) | 168 (81.6) |
| Hazard ratio (95% CI) | 0.67 (0.56–0.81) | 0.64 (0.51–0.80) | ||
| Nominal p-value | <0.0001 | <0.0001 | ||
| Relative decline in FVC ≥5% predicted | 245 (73.8) | 285 (86.1) | 152 (73.8) | 178 (86.4) |
| Hazard ratio (95% CI) | 0.71 (0.60–0.84) | 0.69 (0.55–0.86) | ||
| Nominal p-value | <0.0001 | 0.0006 | ||
| Absolute decline in FVC ≥10% predicted | 114 (34.3) | 160 (48.3) | 77 (37.4) | 99 (48.1) |
| Hazard ratio (95% CI) | 0.64 (0.50–0.81) | 0.69 (0.51–0.93) | ||
| Nominal p-value | 0.0002 | 0.0138 | ||
| Relative decline in FVC ≥10% predicted | 161 (48.5) | 221 (66.8) | 101 (49.0) | 140 (68.0) |
| Hazard ratio (95% CI) | 0.63 (0.51–0.77) | 0.61 (0.47–0.79) | ||
| Nominal p-value | <0.0001 | 0.0001 | ||
Data are presented as n (%), unless otherwise stated. HRCT: high-resolution computed tomography; UIP: usual interstitial pneumonia.